FDA Medical Device Recalls (openFDA)
Boston Scientific Target: Boston Scientific brand Pivot Steerable Microcatheter, 1.9F/2.4F, Catalog #: 1721, Universal Product Number: M00317210, Product is Manufactured by: Boston Scientific - Precision Vascular, 2405 West Orton Cir. West Valley City, UT 84119
- Recall number
- Z-0895-06
- Recalling firm
- Boston Scientific Target
- Product
- Boston Scientific brand Pivot Steerable Microcatheter, 1.9F/2.4F, Catalog #: 1721, Universal Product Number: M00317210, Product is Manufactured by: Boston Scientific - Precision Vascular, 2405 West Orton Cir. West Valley City, UT 84119
- Status
- Terminated
- Initiated
- 2006-04-26
- Posted
- 2006-05-23
- Terminated
- 2006-12-21
- Reason
- During forward advancement, the user may experience increased resistance and may exhibit jump-effect, and this could result in increase in procedure time, or vessel injury, including perforation.
- Root cause
- Other
- Action
- On 4/25/06, the firm initiated the recall notification via letters explaining the reason for the recall and requesting the product be returned.
- Quantity
- 444 units
- Distribution
- The product was released for distribution to 51 consignees in US and 12 foreign consignees: Finland, Austria, Belgium, The Netherlands, Great Britain, Italy, France, Spain, Germany, Poland, Russia and Hong Kong. There were no shipments to U.S. Government facilities or Canadian distribution.
- Lot, serial or model codes
- All codes.
- 510(k) numbers
- ["K050630"]
- PMA numbers
- not on file
- Product code
- KRA
- Firm FEI
- 2939204
- Firm city
- Fremont
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28